GUEST COLUMNISTS

  • Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
    Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”

    With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.

  • FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018

    In this two-part article, FDA Supervisory Consumer Safety Officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 Program Director Art Czabaniuk, and OPQO Division 3 Investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. Part 1 unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

  • Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?
    Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?

    Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?

  • Does Gender Disparity In Biotech Really Matter?
    Does Gender Disparity In Biotech Really Matter?

    Why it does, and how one startup is winning the biotech talent wars with a diversity-centric strategy.

  • Project Execution Models For Biopharmaceutical Facilities
    Project Execution Models For Biopharmaceutical Facilities

    Project execution and project management are probably two of the topics that are most written about but least understood by the biopharmaceutical industry. This article is not about the theory of management, but it is a primer on approaches to project execution, some of which may assist the reader in understanding their path of least risk.

  • Novartis’ Entresto Failure Highlights Need For New HFpEF Trial Designs
    Novartis’ Entresto Failure Highlights Need For New HFpEF Trial Designs

    Heart failure with preserved ejection fraction (HFpEF) remains one of the greatest and most challenging unmet needs in cardiovascular (CV) medicine. In contrast to the significant advances being made in the treatment of heart failure with reduced ejection fraction (HFrEF), little has changed in the approach to treating HFpEF in decades. The lack of effective treatment options is not due to the lack of pipeline activity in this indication but rather due to the 100 percent failure rate of late-stage clinical trials. What is the recipe for designing HFpEF trials with the best chance of success? There are several important considerations.

  • What’s A Cure Worth? ICER Publishes Value Assessment Framework For Curative Therapies
    What’s A Cure Worth? ICER Publishes Value Assessment Framework For Curative Therapies

    The Institute for Clinical and Economic Review (ICER) recently conducted a study of value assessment methods considered for “cures” or “potential cures” and solicited input from international HTA bodies. The research will form the basis of a value framework that will be applied in the assessment of potential cures and other treatments that qualify as what ICER refers to as “single or short-term transformative therapies.”

  • Is Your Personnel Hygiene Plan Up To Date?
    Is Your Personnel Hygiene Plan Up To Date?

    Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

More From Guest Columnists

PHARMA OUTSOURCING WHITE PAPERS

More Pharma Outsourcing White Papers
Louis2019

OUTSOURCED PHARMA CONTENT COLLECTIONS

OP_CDMOGlobalIndustryEbook_300x200

 

Are we dangerously reliant on outsourcing to China, and is this outsourcing without the good of U.S. patients in mind? Our drug development and manufacturing outsourcing industry can’t escape the ins-and-outs of geopolitical and global affairs. Learn more in this free collection of articles

More Content Collections

OUTSOURCING EVENTS

Compounding Pharmacy Compliance September 17 - 18, 2019
San Diego, CA
How to Write SOPs That are GCP Compliant and Implementable September 17 - 17, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Understanding and Implementing the EU Regulation for Initiating and Conducting Clinical Trials September 19 - 19, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers September 24 - 24, 2019
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events